UF-HN-004 Risk Adapted De-Intensification of Radio-Chemotherapy for Favorable Prognosis Oropharyngeal Squamous Cell Carcinoma based on HPV subtype and plasma circulating free HPV DNA Level and Clearance Rate.

Sponsor:

University of Florida

Sponsor Study ID:

UF-HN-004

CTO #:

103706

NCT Number:

NCT05268614

Phase:

II

Protocol Type:

Treatment

Age Group:

Adults

Disease Sites:

Lip, Oral Cavity and Pharynx

Study Objectives:

To determine if Risk-Adapted De-Intensification of RT and chemotherapy based on HPV subtype, cfHPV DNA level, and cfHPV DNA clearance rate produces LRC rates that are similar to what has been achieved with more aggressive therapy in patients with for Favorable Prognosis Oropharyngeal Squamous Cell Carcinoma. To assess the 2-year clinical outcomes of local control (LC), regional control (LRC), disease-free survival (DFS), distant metastasis-free survival (DMFS), and overall survival (OS) in all treated patients. To evaluate the potential value of cfHPV DNA level after treatment to detect residual or recurrent cancer. To evaluate head and neck quality of life assessments before, during, and after RT in all treated patients. To evaluate speech and swallowing function after RT in all treated patients.

eConsent:

Not available

Study Documents:

Open Study Documents
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